Starting to get Involved

In "Notice: Medical Device Single Audit Program (MDSAP) Transition Plan – Frequently Asked Questions (FAQ)",
Health Canada said
"Licences not supported by a valid MDSAP certificate as of January 1, 2019, will be subject to suspension. Holding a valid quality systems certificate is a regulatory requirement for a manufacturer to have an active medical device licence. All device licence applications and F202 notifications received after January 1, 2019, must contain a MDSAP certificate; a manufacturer’s CMDCAS certificate will not be accepted. "

ISO 13485:2003 will be replaced by ISO 13485:2016.

Can anyone tell which version of ISO 13485 is applied for MDSAP certificate?

Re: Which versdion of ISO 13485 would be considered for MDSAP certificate?

I'm in the same situation.

I asked our auditor, and he said that there is no date at present (...mind you, this was some months back).

My plan is to transition to 13485:2016 in a "backward compatible" way. The national requirements (FDA, HC, TGA, ANVISA, MHLW) aren't going to change, so as long as the national requirements of the current MDSAP continue to be met, I don't see a problem with beginning the transition to ISO 13485:2016.

The question is whether to do it now (at big expense - MDSAP is Waaayy more expensive - but potentially beat the rush, and inevitable certification body backlog), or wait until closer to the deadline...

Starting to get Involved

Health Canada says in the following URL website,
"Health Canada has set March 1st 2019, as the transition date to ISO 13485:2016. All manufacturers of class II, III, and IV medical devices holding licences or applying for new or amended licences must complete the transition to ISO 13485:2016 by March 1st, 2019."

Registered

Apparently, they will publish an update of the audit companion in January 2017 including the ISO 13485:2016 requirements though they can have some delay due to the review/comments by all the participating authorities.
Besides, the transition date should be aligned to the ISO 13485:2016 transition.

Registered

01-Mar-18 will be the point where ISO13485:2016 will be used for all ISO13485 assessment including MDSAP. Prior to that it is up to your company - it can be to either depending if you ready for ISO13485:2016 or not..